Sr. Engineer, Process Development

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Amgen seeks a Sr Engineer in Thousand Oaks, CA (or Cambridge, MA) to lead process modeling, risk assessments and technology transfer activities. You will author regulatory documents and coordinate with cross-functional teams to enable robust scale-up and successful commercialization.

The role requires advanced engineering experience, strong communication skills, and a track record in bioprocessing or chemical manufacturing within cGMP environments.

Qualifications

• PhD or MS in chemical engineering or related field.
• Bachelors with 4+ years of engineering experience.
• Associates with 8+ years of engineering experience.

Responsibilities

• Author technical reports and risk assessments for tech transfer.
• Lead scale-up activities and support manufacturing transfer.
• Design, optimize, and deploy process models for kinetics, mass transfer, separations, distillations, and hydrodynamics.
• Evaluate economic value and environmental impact of processes.
• Prepare process documentation for validation and commercialization.
• Collaborate with chemists, formulation scientists and analytics.
• Provide on-the-floor support to troubleshoot and ensure smooth tech transfer.

Skills

Process modeling

Tech transfer

Regulatory documentation

Statistical analysis

Design of experiments

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

HPLC

GC

NMR

Process simulation software

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Engineer

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for authoring technical reports, leading risk assessments, and contributing to regulatory documents through all phases of technology transfer and commercialization.

Position located in either Cambridge, MA or Thousand Oaks, CA.

Domestic and International Travel: up to 20%

• Technical and lab-based execution of bench and kilogram-scale experimentation and process modeling & simulation to design and optimize robust synthetic and hybrid processes.

• Critical evaluation of novel chemical processes for the identification of process improvement opportunities and requirements necessary to ensure safe and successful scale-up and tech transfer.

• Design, optimize, and deploy process models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.

• Model and analyze the economic value and environmental impact of process synthetic processes and manufacturing concepts.

• Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation.

• Represent organization within a multi-functional team to ensure deliverables are aligned with tech transfer timeline, such that key milestones are established and achieved.

• Apply standard and advanced engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.

• Routinely monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance.

• Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer.

• Author, review and/or approve of process documentation needed for process validation and commercialization activities.

• Contribute to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification.

• Provide on-the-floor support to ensure successful scale-up and facilitate rapid problem solving and decision-making.

• Lead or represent department as subject matter expert for process risk analysis.

• Work closely with process development chemists, formulation scientists, and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree
OR
Masters degree and 2 years of Engineering Experience

OR
Bachelors degree and 4 years of Engineering Experience
OR
Associates degree and 8 years of Engineering Experience
OR
High school diploma / GED and 10 years of Engineering Experience

Preferred Qualifications:

• Familiar with bioprocessing unit operations required to support ADCs and/or oligonucleotides, including conjugation and purification.

• Experience in developing and executing experimental plans to evaluate and develop processes to achieve optimum cost, robustness, and productivity.

• Experience related to technology transfer, scale-up and manufacturing of synthetic molecules in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities.

• Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.

• Experience building and utilizing first-principles models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms.

• Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.

• Experience using data science and/or advanced statistical analysis to solve processing issues and evaluate opportunities for process improvements.

• Proficient understanding of regulatory and cGMP requirements.

• Command of lab and plant operations and associated safety practices.

• Familiarity with HPAPI processing and containment. Engineering knowledge around linker payload chemistry and scale-up.

• Strong communication and presentation skills

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.